USPTO Patents Application 10687850

PCT

WORLD INTELLECTUAL PROPERTY ORGANIZATION
International Bureau

INTERNATIONAL APPLICATION PUB LIS PIED UNDER THE PATENT COOPERATION TREATY (PCT)

(51) International Patent Classification 7 :
G01N 33/487, A61B 5/145

Al

(11) International Publication Number: WO 00/54047

(43) International Publication Date: 14 September 2000 (14.09.00)

(21) International Application Number: PCT/US00/06171

(22) International Filing Date: 9 March 2000 (09.03.00)

(30) Priority Data:
09/267,179

12 March 1999(12.03.99)

US

(71) Apphcant: INTEG, INC. [US/US]; 2800 Patton Road, St Paul,

MN 55113 (US).

(72) Inventors: ALLEN, John, J.; 1020 Brompton Place, Mendota

Heights, MN 55188 (US). RACCHINI, Joel, R.; 4221 W.
44th Street, Edina, MN 55424 (US).

(74) Agent: BRUESS, Steven, C; Merchant & Gould P.C., P.O.
Box 2903, Minneapolis, MN 55402-0903 (US).

(81) Designated States: AE, AL, AM, AT, AT (Utility model), AU,
AZ, BA, BB, BG, BR, BY, CA, CH, CN, CR, CU, CZ, CZ
(Utility model), DE, DE (Utility model), DK, DK (Utility
model), DM, DZ, EE, EE (Utility model), ES, FI, FI (Utility
model), GB, GD, GE, GH, GM, HR, HU, ID, IL, IN, IS,
JP, KE, KG, KP, KR, KR (Utility model), KZ, LC, LK,
LR, LS, LT, LU, LV, MA, MD, MG, MK, MN, MW, MX,
NO, NZ, PL, PT, RO, RU, SD, SE, SG, SI, SK, SK (Utility
model), SL, TJ, TM, TR, TT, TZ, UA, UG, UZ, VN, YU,
ZA, ZW, ARIPO patent (GH, GM, KE, LS, MW, SD, SL,
SZ, TZ, UG, ZW), Eurasian patent (AM, AZ, BY, KG, KZ,
MD, RU, TJ, TM), European patent (AT, BE, CH, CY, DE,
DK, ES, FI, FR, GB, GR, IE, IT, LU, MC, NL, PT, SE),
OAPI patent (BF, BJ, CP, CG, CI, CM, GA, GN, GW, ML,
MR, NE, SN, TD, TG).

Published

With international search report.

Before the expiration of the time limit for amending the
claims and to be republished in the event of the receipt of
amendments.

(54) Title: COLLECTION WELL FOR BODY FLUID TESTER
(57) Abstract

A body fluid is collected for testing for
an analyte contained within the body fluid. The
fluid is collected in an apparatus (10) including
a reservoir (30) for receiving and collecting a
flow of body fluid from a discharge end (24) of
a conduit (20). A capillary test space is in fluid
flow communication with the reservoir (30). The
capillary test space (48) is sized to wick the fluid
from the reservoir (30) when the fluid contacts the
capillary test space.

10.

(4

FOR THE PURPOSES OF INFORMATION ONLY

Codes used to identify States party to the PCT on the front pages of pamphlets publishing international applications under the PCT.

AL

Albania

ES

Spain

LS

Lesotho

SI

Slovenia

AM

Armenia

FI

Finland

LT

Lithuania

SK

Slovakia

AT

Austria

FR

France

LU

Luxembourg

SN

Senega]

AU

Australia

GA

Gabon

LV

Latvia

sz

Swaziland

AZ

Azerbaijan

GB

United Kingdom

MC

Monaco

TD

Chad

6A

Bosnia and Herzegovina

GE

Georgia

MD

Republic of Moldova

TG

Togo

BB

Barbados

GH

Ghana

MG

Madagascar

TJ

Tajikistan

BE

Belgium

GN

Guinea

MK

The former Yugoslav

TM

Turkmenistan

BF

Burkina Faso

GR

Greece

Republic of Macedonia

TR

Turkey

BG

Bulgaria

HU

Hungary

ML

Mali

TT

Trinidad and Tobago

BJ

Benin

IE

Ireland

MN

Mongolia

LA

Ukraine

BR

Brazil

IL

Israel

MR

Mauritania

UG

Uganda

BY

Belarus

IS

Iceland

MW

Malawi

US

United States of America

CA

Canada

IT

Italy

MX

Mexico

UZ

Uzbekistan

CF

Central African Republic

JP

Japan

NE

Niger

VN

Viet Nam

CG

Congo

KE

Kenya

NL

Netherlands

YU

Yugoslavia

CH

Switzerland

KG

Kyrgyzstan

NO

Norway

ZW

Zimbabwe

CI

C6te d'Tvoire

KP

Democratic People's

NZ

New Zealand

CM

Cameroon

Republic of Korea

PL

Poland

CN

China

KR

Republic of Korea

PT

Portugal

cu

Cuba

KZ

Kazakstan

RO

Romania

cz

Czech Republic

LC

Saint Lucia

RU

Russian Federation

DB

Germany

LI

Liechtenstein

SD

Sudan

DK

Denmark

LK

Sri Lanka

SE

Sweden

EE

Estonia

LR

Liberia

SG

Singapore

WO 00/54047

PCT/US00/06171
COLLECTION WELL FOR BODY FLUID TESTER

TECHNICAL FIELD

This invention pertains to testing a body fluid for an analyte. For example,
5 the present invention is applicable for testing glucose in a body fluid such as blood
or interstitial fluid.

BACKGROUND

Numerous patents teach various ways for collecting a sample of body fluid

10 and testing such fluid for an analyte such as glucose. For example, United States
Patents 5,823,973 and 5,820,570 describe methods and apparatus for obtaining, in
one embodiment, interstitial fluid, which is tested for glucose through IR absorption.
These patents also describe use of the disclosed inventions in colormetric and
electro-chemical testing of glucose. U.S. Pat. No. 5,453,360 teaches a test strip for

15 colormetric testing for glucose. Blood is placed on a test strip containing various
chemical components including a dye. The degree of color change of the test strip
indicates the amount of glucose. United States Patents 5,508,171 and 5,628,890
teach electro-chemical testing. Blood is placed on a test strip containing electrodes.
Reaction of glucose on the electrodes generates a current indicating the amount of

20 glucose present in the blood.

Present development efforts are directed to testing very small volumes of
body fluid (e.g. about 0.5 microliter). The use of such small volumes of fluid
permits less painful collection of a fluid samples. However, small fluid volumes
present additional challenges for analyte testing. For example, testing for analytes

25 typically requires a fluid sample in excess of a predetermined minimum volume. By
way of non-limiting representative example, a test may require a minimum sample
size of 5 microliter to yield reliable test results.

Furthermore, sample collection systems may receive a flow of body fluid
over an extended time (e.g., 10 seconds or more) before a minimum sample volume

30 is collected. As a result, body fluid may be deposited on test components (e.g.,
electrodes or colormetric test strips) before a full sample is collected. Such
premature deposit may initiate chemical reactions on a test strip thereby consuming

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reagents before a reliable test can be initiated. Further, such test components may be
coupled to logic circuits for calculating an analyte's concentration based on readings
from the test strip. A premature deposit of an inadequate volume of fluid sample
may falsely inform logic circuits that testing has initiated when, in fact, an adequate
5 sample volume has yet to be collected.

Recognizing the problems of premature test initiation, the prior art has
developed techniques for delaying test initiation until an adequate volume of sample
is collected. For example, logic circuits may have a built-in time delay which
assumes a fixed period of time to collect an adequate volume of sample. Of course,

1 0 such systems suffer from the fact there is no certainty that an adequate volume is

collected during such time delay. Alternatively, to be conservative, such time delays
may frequently be unnecessarily long. Additionally, United States Patent
5,049,487 teaches reading a reflectance of a side of a membrane. A fluid sample is
placed on the opposite side. When the sample is absorbed through the membrane,

15 the change in reflectance is noted indicating testing may commence. However, such
a system suffers from chemical agents on the membrane being in contact with a
sample prior to initiating testing.

Therefore, there is a need for a method and apparatus for collecting a sample
of body fluid to obtain an adequate volume of such fluid.

20

SUMMARY

According to a preferred embodiment of the present invention, a method and
apparatus are disclose for collecting a body fluid for testing for an analyte contained
within the body fluid. The apparatus includes a reservoir for receiving and

25 collecting a flow of body fluid from a discharge end of a conduit. A capillary test
space is in fluid flow communication with the reservoir. The capillary test space is
positioned to be in contact with the fluid in the reservoir after the fluid has
accumulated to a predetermined transfer volume of fluid. The capillary test space is
sized to wick the fluid from the reservoir when the fluid contacts the entrance end.

30 With the present invention, fluid is collected within the reservoir at a rate of flow
r limited by the conduit. When the reservoir is full, the collected fluid rapidly wicks

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into the capillary test space. The capillary test space may contain test components
for testing for the analyte.

BRIEF DESCRIPTION OF THE DRAWINGS

5 Fig. 1 is a perspective view of a sample collection apparatus with an electro-

chemical test strip shown removed;

Fig. 2 is an enlarged segmented view of the area of circle 2 in Fig. 1;
Fig. 3 is a side-sectional view of the apparatus of Fig. 1 showing the test strip
in place;

10 Fig. 4 is an enlarged segmented view of the area of circle 4 in Fig. 3 ;

Fig. 5 is a segmented top-plan view of a reservoir of the apparatus of Fig. 1 ;

Fig. 6 is a view taken along line 6-6 in Fig. 3 and showing a bolus of body
fluid residing in a capillary test space;

Fig. 7 is a top plan view of a first alternative embodiment of the present
15 invention;

Fig. 8 is a view taken along line 8-8 of Fig. 7;

Fig. 9 is a view similar to Fig. 8 showing a second alternative embodiment of
the present invention;

Fig. 10 is a view similar to those of Figs. 8 and 9 showing a third alternative
20 embodiment of the present invention;

Fig. 1 1 is a top plan view of the embodiment of Fig. 10 with a test strip
removed; and

Fig. 12 is a view similar to Fig. 1 1 showing a fourth alternative embodiment
of the present invention

25

DETAILED DESCRIPTION

With reference to the various drawing figures in which identical elements are
numbered identically throughout, a description of a preferred embodiment will now
be provided. Throughout this description, the present invention will be described
30 with reference to collecting a sample of interstitial fluid for glucose testing using a
narrow needle that penetrates into, but not through, the dermis as more fully
described in commonly assigned United States Patents 5,823,973 and 5,820,570, the

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WO 00/54047 PCT/USOO/06171

disclosures for both of which are hereby incorporated herein by reference. While
such a use is a preferred embodiment, the present invention is applicable to other
fluid collection systems (e.g., blood collection) as well as testing for other fluid
analytes. Further, the present invention is described with reference to using electro-
5 chemical testing of a collected sample. The teachings of the present invention are
equally applicable to other testing methods such as colormetric testing and IR
absorption testing.

Referring now to Figures 1-6, a collection apparatus 10 includes a main body
12 and a test strip 14. The main body has a handle 16 and a needle-containing

1 0 ferrule 1 8. The ferrule 1 8 holds a hollow needle 20 extending from a penetration
end 22 to a discharge end 24. The penetration end 22 protrudes from a radially
spaced ring end 26 of the ferrule 18.

In a preferred embodiment, the penetration end 22 is axially spaced from ring
end 26 by a distance sufficient for the needle 20 to penetrate into but not through a

1 5 patient's dermis to collect a sample of substantially blood-free interstitial fluid as

taught in United States Patent 5,820,570. In such an embodiment, the outer diameter
of the needle is about .013 inch (about 0.33 mm). This sizing of the needle permits
substantially pain-free penetration of the needle to collect a body fluid. This
description illustrates a preferred embodiment. Needle 20 may be sized to collect

20 any body fluid such as blood or interstitial fluid. Further, the present invention is
disclosed where the skin penetration member (i.e., the needle 20) also serves as a
conduit for supplying fluid to a reservoir 30 as will be described. The present
invention is also applicable to any conduit for transporting a body fluid (e.g., a
capillary tube as described in International Application PCT/US97/08400 published

25 November 20, 1997 as International Publication No. WO 97/42883).

The test strip 14 contains exposed test components on an inner surface 14a.
The test components are shown in the form of electrodes 32 for testing a body fluid
for an analyte such as glucose through electro-chemical testing. As previously
described, the test components could be components for alternate testing techniques

30 such as colormetric or IR absorption testing.

Not shown is a housing for holding the apparatus 1 0 during sample
collection and testing. Housings for holding disposable body fluid samplers are

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WO 00/54047 _ PCT/US00/06171

shown in United States Patent 5,823,973. Such housings may contain electrical
components for electrical connection to the test strip electrodes 32 to connect a
signal from the electrodes 32 to logic circuits to compute and report on the analyte in
response to signals from the electrodes 32 during testing.
5 The material of the main body 12 defines a cylindrical reservoir 30 having a

cylindrical axis between a first end 34 and a second end 36. In the embodiment
shown, the axis of the reservoir 30 is perpendicular to the axis of the needle 20.
Such a relative alignment is not necessary for adequate function and any other
alignment is acceptable.

1 0 The reservoir 30 has a volume at least as great as a desired test volume of

body fluid to be tested. In a preferred embodiment, reservoir 30 has a volume of 0.7
microliters. As will become apparent, fluid is collected in the reservoir 30 and
accumulates with a fluid level rising from the first end 34 toward the second end 36.
Due to such small volumes and the geometry of reservoir 30, surface tension assures

1 5 the fluid is retained in the reservoir 30 with the fluid level rising as described

regardless of the orientation of the apparatus 10 (i.e., the operation of the apparatus
1 0 is gravity independent).

The discharge end 24 of the needle 20 is disposed within the reservoir 30
adjacent the first end 34. Accordingly, body fluid is transported from the

20 penetration end 22, through needle 20 and discharged from the discharge end 24 into
the reservoir 30 at the first end 34.

The material of the body 12 also defines an enlarged empty volume 3 8
positioned between the reservoir 30 and the ferrule 18 and surrounding the needle
20. The enlarged volume 38 is separated from the reservoir 30 by material of the

25 main body pinching against the needle 20 as at locations 40. The enlarged volume
38 has a volume larger than the reservoir 30 and ensures that fluid within the
reservoir 30 is retained within reservoir 30 as it accumulates. For example, in the
absence of enlarged volume 38, manufacturing tolerances may result in a narrow
spacing between the material of main body 12 and needle 20. Such a narrow

30 spacing could function as a capillary space communicating with reservoir 30 which
would wick fluid out of reservoir 30. The enlarged volume 38 precludes such
capillary wicking. Further, the material defining the volume 38 is preferably

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hydrophobic to minimize wicking. In the event precise manufacturing permits
complete liquid-tight sealing around needle 20, the enlarged volume 38 could be
eliminated.

The test strip 14 is secured to the main body (e.g., through adhesives) with
5 the inner surface 14a facing the main body 12 and overlying the second end 36 of
the reservoir 30. The main body 12 includes a groove 42 shaped complementary to
the outer periphery of the test strip 14 to ensure accurate alignment of the test strip
14 with the main body 12. Adjacent its outer periphery, the inner surface 14a of the
test strip 14 includes spacers 44 (shown best in Fig. 6). The spacers 44 insure
1 0 uniform and close parallel spacing of the inner surface 14a from a test strip opposing
surface 12a of the main body 12 for reasons that will become apparent.
Alternatively, spacers could be formed on the body 12 thereby eliminating the need
for spacers 44.

The test strip opposing surface 12a includes a step 46. With reference to Fig.

15 6, the construction described above results in formation of a capillary test space 48
defined between opposing surfaces of the test strip inner surface 1 4a and step 46.

As shown in Fig. 6, the spacers 44 are spaced from opposing surfaces of the
step 46 thereby defining enlarged volumes 50 on opposite sides of the step 46. The
enlarged volumes 50 perform a function similar to that of enlarged volume 38.

20 Namely, if the spacers 44 were sized to abut step 46, small capillary spaces could
form between the spacers 44 and step 46. Such capillary spaces could wick fluid
from the fluid receiving volume 48. Again, if manufacturing could ensure a fluid-
tight seal between spacers 44 and step 46, the volumes 50 could be eliminated.

Shown best in Figs. 4 and 6, the electrodes 32 are positioned opposing the

25 step 46. Further, the spacing S (Fig. 4) between the step 46 and inner surface 14a is
uniform and is selected to be sufficiently narrow for the capillary test space 48 to act
as a capillary space to wick fluid from the reservoir 30. An entrance end 52 of the
capillary test space 48 is positioned at the second end 36 of the reservoir 30 (Fig. 4).
The preferred spacing S is about .003 - .005 inch (about .075 mm to .125 mm). The

30 spacing S may be as large as .012 inch (about .300 mm) or larger depending on the
surface tension and volume of the fluid being collected and the relative
hydrophobic/hydrophilic characteristics of the main body 12 and test strip 14.

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WO 00/54047 . PCT/US00/06171

A hole 54 is formed through the body 12 and into the fluid receiving volume
48 on a side of the step 46 opposite the reservoir 30. The hole 54 permits air in the
capillary test space 48 to be vented to atmosphere as fluid flows into the capillary
test space 48 from the reservoir 30. Volumes 50 also provide venting.
5 An additional advantage of this embodiment is its ability to minimize the

effects of sample concentration via evaporation. The total air volume contained
within the enclosed sections substantially defined by volume 38, reservoir 30, the
capillary test space 48, and adjoining volumes spaces, is sufficiently small so as to
provide a very low capacity for evaporation of water from the aqueous sample being

10 collected. In addition, the location of the vent and the overall geometry discourage
convective passage of air through the aforementioned spaces, minimizing any
convective acceleration of evaporation. When dealing with small volumes (e.g. less
than 1 microliter), minimizing evaporative losses can be important to maintaining
the integrity of the sample for quantitative analysis.

1 5 With the construction thus described, the apparatus 1 0 is used by urging the

ring end 26 against a patient's skin. The penetration tip 22 penetrates the skin. The
ring end 26 (being radially spaced from tip 22) acts to urge fluid into the needle 20.
The fluid flows along the needle 20 and discharges into the first end 34 of the
reservoir 30 through discharge end 24. In one possible embodiment, suction could

20 be applied to advance the rate of flow of fluid through needle 20. Suction is not .
used in other embodiments.

Fluid accumulates in the reservoir 30 with a level of accumulated fluid
growing from the first end 34 to the second end 36. When the fluid level reaches the
second end 36, a desired volume of fluid to be tested has accumulated in the

25 reservoir 30. At this time, the fluid level contacts the entrance end 52 of the

capillary test space 48. Since the capillary test space 48 is a narrow capillary space,
the fluid is rapidly wicked out of the reservoir 30 and into the capillary test space 48
as a bolus delivery of fluid indicated by the bolus of fluid 56 in Fig. 6. So
positioned, the fluid is in contact with the electrodes 32 and testing of the fluid may

30 commence.

The present invention permits fluid contact with the electrodes 32 only after
an adequate volume of fluid has been collected. By way of non-limiting

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WO 00/54047 _ PCT/USOO/06171

representative example, it may take thirty seconds for fluid to fill the reservoir 30
and only one second for the accumulated fluid to be wicked into the capillary test
space 48 from the reservoir 30. As a result, the present invention avoids a long
period of time during which fluid is contacting the electrodes 32 and before testing
5 may commence. Further, without the need for specialized electronics as used in the
prior art, testing cannot commence until after an adequate volume of fluid has been
accumulated. Therefore, when a signal is received from electrodes 32, it is known
that an adequate volume of fluid is opposing the electrodes 32.

The retention of fluid in the reservoir 30 and wicking of fluid into the

10 capillary test space 48 can be controlled and modified by varying the dimensions of
the components as will be apparent to one of ordinary skill in the art having the
benefit of the teachings of the present invention. Further, as will be apparent to such
artisan, such retention and wicking may also be controlled and modified through
material selection. For example, it is desirable that the main body 12 be formed of

1 5 hydrophobic material and that the capillary test space 48 be more hydrophilic. For
example, a hydrophilic surfactant may be applied to step 46 or test strip inner surface
14a (or both) to make the capillary test space 48 more hydrophilic than the reservoir
30.

It may be desirable to have one of electrodes 32 completely wetted with fluid
20 from reservoir 30 before the other of the electrodes 30 is wetted. Figs. 7-12

illustrate several alternative embodiments for achieving such sequential wetting. In
the embodiments, elements in common with those already described are numbered
identically with the addition of letter suffices (i.e., "a", "b", "c" and "d"). Such
elements are not separately described unless modified by the alternative
25 embodiment.

In Figs. 7 and 8, it is desirable to completely wet electrode 32a before
wetting electrode 32a' . The electrodes 32a, 32a' are positioned side-by-side on test
strip 14a and equidistant from reservoir 30a. As shown in Fig. 8, the step 46 of the
previously described embodiment is divided into two steps 46a, 46a' opposing
30 respective ones of electrodes 32a, 32a\ A hydrophobic volume 50a' is positioned
between the steps 46a, 46a'. The volume 50a' functions similarly to side volumes
50a (and 50 in the embodiment of Fig. 6) to act as a hydrophobic barrier to prevent

8

WO 00/54047 . PCT/US00/06171
fluid from flowing between the steps 46a, 46a'. The steps 46a, 46a' are spaced from
test strip 14 by spaces Sa and Sa'. Since space Sa is smaller than space Sa\ fluid
first flows from reservoir 30a into space Sa before flowing from reservoir 30a into
space Sa\

5 In the embodiment of Fig. 9, fluid is inclined to first flow onto step 46b

before onto step 46b'. However, in Fig. 9, the volume barrier 50a' of Fig. 8 has
been replaced with a ramp surface 47b connecting steps 46b and 46b'. Therefore,
fluid can flow from space Sb to space Sb' after space Sb has first filled with fluid.
In the embodiment of Figs. 10 and 11, the steps 46c, 46c' are positioned on
10 opposite sides of the reservoir 30c. If spaces Sc and Sc' are equal, fluid flows

simulataneously into the spaces Sc and Sc' but does not flow between the spaces Sc
and Sc'. The spaces Sc and Sc' may be varied to change the rate of flow into the
spaces Sc and Sc'.

The embodiment of Fig. 12 is similar to that of Fig. 9. Instead of the ramp
1 5 47b of Fig, 9 (which connects steps 46b and 46b' directly across a side-to-side path),
the ramp 47d is U-shaped for fluid to flow from step 46d to step"46d' in a U-shaped
path A on a side of the steps 46d, 46d' opposite the reservoir 30d.

From the foregoing detailed description, the present invention has been
described in a preferred embodiment. Modifications and equivalents of such
20 disclosure are intended to be included in the appended claims. For example, either
or both of the reservoir 30 and capillary test space 48 need not be an empty volume
but could be filled with an absorbent material.

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PCT/US00/06171

The Claimed Invention Is:

1 . An apparatus for collecting a body fluid for testing for an analyte contained
within said body fluid, said apparatus comprising:

a reservoir for receiving and collecting a flow of body fluid from a discharge end
5 of a conduit;

a capillary test space positioned to be in contact with said fluid in said reservoir
after said fluid has accumulated within said reservoir to a transfer volume of fluid;
and

said capillary test space sized to wick said fluid from said reservoir when said
1 0 fluid in said reservoir attains said transfer volume.

2. An apparatus according to claim 1 further comprising:

test components within said capillary test space for testing said fluid for said
analyte.

15

3. An apparatus according to claim 2 wherein:

said test components include electrodes for electro-chemically testing said fluid;
said electrodes positioned within said capillary test space to be in contact with
said fluid after said fluid is wicked into said capillary test space.

20

4. An apparatus according to claim 1 wherein:

said reservoir includes first and second spaced-apart ends;

said discharge end of said conduit disposed adjacent said first end; and

said capillary test space is disposed adjacent said second end.

25

5. An apparatus according to claim 4 wherein a volume of said reservoir between
said first and second ends of said reservoir is sized to be at least as great as said
transfer volume.

30 6. An apparatus according to claim 1 wherein said capillary test space is vented.

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7. An apparatus according to claim 1 wherein material defining said capillary test
space is more hydrophilic than material defining said reservoir.

8. An apparatus according to claim 1 wherein:

5 said conduit is a needle extending from a penetration end to said discharge end;
said needle penetration end being exposed for penetration into a patient's skin to
access body fluid for said fluid to flow along said needle and discharged into said
reservoir at said discharge end.

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30 36 52 32 48 14 32

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FI6.11

FI6.12

INTERNATIONAL SEARCH REPORT

Inb .tional Application No

PCT/US 00/06171

A. CLASSIFICATION OF SUBJECT MATTER ,

IPC 7 G01N33/487 A61B5/145

According to International Patent Classification (IPC) or to both national classification and IPC

B. FIELDS SEARCHED

Minimum documentation searched (classification system followed by classification symbols)

IPC 7 G01N A61B

Documentation searched other than minimum documentation to the extent that such documents are included in the fields searched

Electronic data base consulted during the international search (name of data base and, where practical, search terms used)

EPO-Internal

C. DOCUMENTS CONSIDERED TO BE RELEVANT

Category • Citation of document, with indication, where appropriate, of the relevant passages

Relevant to dalm No.

EP 0 306 158 A (THORN EMI PLC)

8 March 1989 (1989-03-08)

column 1, line 53 -column 2, line 40

EP 0 396 016 A (SPACELA8S, INC.)
7 November 1990 (1990-11-07)
column 8, line 13 - line 34
column 9, line 30 - line 44
column 10, line 21 - line 33

W0 97 38126 A (MERCURY DIAGNOSTICS, INC.)

16 October 1997 (1997-10-16)

page 25, line 8 - line 28

page 27, line 6 -page 28, line 8

page 34, line 9 - line 17

1-3

1,3,4,6,
8

1,6
4

□

Further documents are listed in the continuation of box C.

m

Patent family members are listed in annex.

0 Special categories of cited documents :

-A" document defining the general state of the art which Is not

considered to be of particular relevance
"E" earlier document but published on or after the international

filing date

"L" document which may throw doubts on priority claim(s) or
which is cited to establish the publication date of another
citation or other special reason (as specified)

"O" document referring to an oral disclosure, use, exhibition or
other means

"P" document published prior to the international filing date but
later than the priority date claimed

T* later document published after the International filing date
or priority date and not In confBct with the application but
cited to understand the principle or theory underlying the
Invention

"X" document of particular relevance; the claimed invention
cannot be considered novel or cannot be considered to
involve an inventive step when the document is taken alone

"Y" document of particular relevance; the claimed Invention

cannot be considered to Involve an Inventive step when the
document is combined with one or more other such docu-
ments, such combination being obvious to a person skilled
In the art.

"&" document member of the same patent family

Dale of the actual completion of the international search

3 August 2000

Date of mailing of the International search report

10/08/2000

Name and mailing address of the ISA

European Patent Office, P.B. 5818 Patentlaan 2
NL - 2280 HV RQswijk
Tel. (+31 -70) 340-2040. Tx. 31 651 epo nl,
Fax: (+31-70) 340-3016

Authorized officer

R1eb, K.D.

Foot PCT/tSA/210 (second sheer) (Jury 1 992)

INTERNATIONAL SEARCH REPORT

Information on patent family members

Intt .tlonal Application No

PCT/US 00/06171

Patent document

Publication

Patent family

Publication

cited in search report

date

member(s)

date

EP 306158 A

08-03-1989

AT

94284 T

15-09-1993

DE

3883895 D

14-10-1993

DE

3883895 T

24-03-1994

JP

1072049 A

16-03-1989

JP

2829000 B

25-11-1998

US

5064618 A

12-11-1991

EP 396016 A

07-11-1990

US

5145565 A

08-09-1992

CA

2015287 A C

01-11-1990

w A XX i77U

JP

3063570 A

19-03-1991

W0 9738126 A

16-10-1997

US

5962215 A

05-10-1999

AU

2608297 A

29-10-1997

DE

19781096 T

17-12-1998

DE

29723391 U

20-08-1998

EP

0906447 A

07-04-1999

GB

2322699 A

02-09-1998

JP

11508693 T

27-07-1999

Form PCT/ISA/2 10 (patent family annex) (Jdy 1992)